Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05775029
Status:
RECRUITING
Last Update Posted:
2023-03-27
First Post:
2022-05-05
Brief Title:
RSI Observation Follow-up
Sponsor:
Jakob Zeuchner
Organization:
Linkoeping University
Study Overview
Official Title:
Rapid Sequence Induction Checklist and Its Effect on Compliance to Guidelines and Complications - Follow-up
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this prospective observational study is to determine if compliance to local guildelines for the RSI procedure after introduction of a RSI-check list persists over time 36-60months Any changes in complication rates will also be evaluated
Detailed Description:
A prospective observational study of long-term compliance to local RSI guidelines performed at two hospitals in Region Östergötland County Sweden All staff members specialist anaesthetist nurse-anaesthetist resident anaesthetist performing RSI in adult patients 18 years of age are eligible for inclusion Exclusion criteria are refusal to participate or RSI performed in patients 18 years old All members of the staff at the participating centres will be given oral and written information about the study and consent is implied by completion of the questionnaire
A standard RSI checklist was introduced in the two hospitals during 2017-2018 The checklist is a 16-item document consisting of statements requiring binary yesno and check type answers and was designed to encourage consistency and completeness in RSI preparations and execution The statements were based on prior data in literature regarding the RSI procedure Initial compliance was good when measured at 12 months after implementation of the RSI-checklist and a supporting educational program Reference 1Study results
The investigators plan to evaluate the long-term compliance to the RSI-checklist Nurse anaesthetists or anaesthetists attending the patient during RSI will complete a predefined questionnaire about the conduct of RSI and RSI-related complications The questionnaire will be completed immediately after induction when the patient is stable
The investigators plan to conduct duplicate measurements in 20 of the observations to test inter-rater variability and to mitigate the risk of bias due to self-reporting
Primary hypothesis Compliance to local RSI-guidelines is maintained 36 months after introduction of a pre-RSI checklist
Secondary hypothesis Increased compliance to local RSI-guidelines 36 months after introduction of a pre-RSI checklist reduces the frequency of complications
Outcome
Primary outcome Compliance to local RSI-guidelines
Compliance categories were defined by consensus of the authors and individual parameters were not weighted It is measured as a 7-point score one point for the fulfilment of each seven parameters
1 100 FiO2 with FGF 10 Lmin for 3 minutes
2 Use of Thiopental or Ketamine
3 Use of Succinylcholine
4 Use of an Orogastric tube
5 Use of a stylet in the endotracheal tube
6 Administration of Sodium Citrate
7 Reverse Trendelenburg or supine patient position
Secondary outcome Frequency of complications during RSI
Complications are defined as according to the Swedish Perioperative Registry
A111 Unexpected difficult airway 2 unsuccessful attempts to intubate the patient by an experienced anesthesiologist OR intubation by another more experienced anesthesiologist than the anesthesiologist responsible for induction
A126 Hypoxia that requires intervention eg increased fiO2 Hypoxia SpO2 90
A215 Bradycardia that requires specific pharmacological intervention or change in anesthetic strategy A222 Hypotension that requires unplanned continuous administration of vasopressor drug
A514 Dental injury
A standard RSI checklist was introduced in the two hospitals during 2017-2018 The checklist is a 16-item document consisting of statements requiring binary yesno and check type answers and was designed to encourage consistency and completeness in RSI preparations and execution The statements were based on prior data in literature regarding the RSI procedure Initial compliance was good when measured at 12 months after implementation of the RSI-checklist and a supporting educational program Reference 1Study results
The investigators plan to evaluate the long-term compliance to the RSI-checklist Nurse anaesthetists or anaesthetists attending the patient during RSI will complete a predefined questionnaire about the conduct of RSI and RSI-related complications The questionnaire will be completed immediately after induction when the patient is stable
The investigators plan to conduct duplicate measurements in 20 of the observations to test inter-rater variability and to mitigate the risk of bias due to self-reporting
Primary hypothesis Compliance to local RSI-guidelines is maintained 36 months after introduction of a pre-RSI checklist
Secondary hypothesis Increased compliance to local RSI-guidelines 36 months after introduction of a pre-RSI checklist reduces the frequency of complications
Outcome
Primary outcome Compliance to local RSI-guidelines
Compliance categories were defined by consensus of the authors and individual parameters were not weighted It is measured as a 7-point score one point for the fulfilment of each seven parameters
1 100 FiO2 with FGF 10 Lmin for 3 minutes
2 Use of Thiopental or Ketamine
3 Use of Succinylcholine
4 Use of an Orogastric tube
5 Use of a stylet in the endotracheal tube
6 Administration of Sodium Citrate
7 Reverse Trendelenburg or supine patient position
Secondary outcome Frequency of complications during RSI
Complications are defined as according to the Swedish Perioperative Registry
A111 Unexpected difficult airway 2 unsuccessful attempts to intubate the patient by an experienced anesthesiologist OR intubation by another more experienced anesthesiologist than the anesthesiologist responsible for induction
A126 Hypoxia that requires intervention eg increased fiO2 Hypoxia SpO2 90
A215 Bradycardia that requires specific pharmacological intervention or change in anesthetic strategy A222 Hypotension that requires unplanned continuous administration of vasopressor drug
A514 Dental injury
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None